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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC BACK TABLE COVER IN CATARACT PACK

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MEDLINE INDUSTRIES INC BACK TABLE COVER IN CATARACT PACK Back to Search Results
Catalog Number LYN051BSOGA
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/14/2016
Event Type  Injury  
Manufacturer Narrative

Blue fibers thought to be from back table cover in cataract pack found in surgical site. Fibers flushed out of site, incision did not have to be enlarged to remove the fibers. No injury or need for further intervention. Sample has not been returned, have not confirmed the issue or identified a root cause. Due to the need for intervention to remove the blue fibers this medwatch is being filed. Device not returned.

 
Event Description

Blue fibers thought to be from the back table cover were seen in the surgical site.

 
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Type of DeviceBACK TABLE COVER IN CATARACT PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC
one medline place
mundelein IL 60060
Manufacturer Contact
julie finley
one medline place
mundelein, IL 60060
8476434709
MDR Report Key6026500
MDR Text Key57318563
Report Number1423395-2016-00047
Device Sequence Number1
Product Code OJK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 10/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLYN051BSOGA
Device LOT Number16DB2569
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/13/2016 Patient Sequence Number: 1
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